Compliance & Facilities Engineer - Part-Time

ROLE OVERVIEW

The Facilities & Compliance Engineer is responsible for the operation and maintenance of site facilities within a GMP manufacturing environment, with a strong emphasis on regulatory compliance. This role owns facilities-related SOPs, supports audit readiness, and manages Non-Conformance (NC) and CAPA processes, while overseeing contractor and vendor performance across facilities and soft services.

KEY RESPONSIBILITIES

• Manage key equipment/systems including architectural & building maintenance, clean room maintenance, fire protection systems, painting, docks, grounds, pest control, staff amenities, janitorial services, cGMP cleaning and sanitization, and gowning services
• Own facilities-related SOPs, including authoring, revising, and driving continuous improvement
• Own facilities services-related Non-Conformance (NC) and Corrective Action and Preventive Action (CAPA)
• Provide support in preparation of audit room and war room, and ensure facility readiness for internal and regulatory audits
• Partner with vendors, establish KPIs, and perform audits for vendor service contracts to ensure performance against SLA
• Supervise and monitor contractor performance in accordance with established KPIs
• Maintain facilities work orders relating to routine and non-routine facilities maintenance
• Maintain high standards of cleanliness across zones in compliance with QA requirements
• Coordinate and manage the pest control service program, including follow-up on incidents and investigations
• Attend SQDIP and production coordination meetings as required
• Provide training as required and maintain all records necessary to satisfy SOPs and GxP requirements
• Partner with EHSS to develop and manage sustainability initiatives
• Manage facility improvement works and support facilities-related cost saving projects
• Oversee facilities soft services including couriers, stationery, meeting rooms, cafe/pantry operations, and bus services
• Participate actively in the site emergency response team and relevant EHS training
• Support site activities and engagement initiatives across the plant

QUALIFICATIONS & EXPERIENCE

• Bachelor's degree in Engineering, Facilities Management, or related field
• Minimum 5 years of engineering, operations, or facilities experience within a GMP-regulated environment
• Strong working knowledge of GMP/GDP concepts and their practical application in a facilities context
• Demonstrated experience authoring or revising SOPs (not limited to executing them)
• Prior involvement in internal or regulatory audits (e.g. FDA, EU GMP, client/internal QA audits)
• Knowledge of NC/CAPA and Change Control processes, engineering documentation, drawing or records management
• Experience managing contractors and vendors
• Good interpersonal and communication skills with high computer literacy
• Strong customer service focus and professional disposition